Bariatric device and method

ABSTRACT

A bariatric device and method of causing weight loss in a recipient includes providing a bariatric device having an esophageal member, a cardiac member and a connector connected with the esophageal member and the cardiac member. The esophageal member has an esophageal surface that is configured to generally conform to the shape and size of a portion of the esophagus. The cardiac member has a cardiac surface that is configured to generally conform to the shape and size of a portion of the cardiac portion of the stomach. The esophageal surface is positioned at the esophagus. The cardiac surface is positioned at the cardiac portion of the stomach. The bariatric device stimulates receptors in order to influence a neurohormonal mechanism in the recipient.

CROSS REFERENCE TO RELATED APPLICATIONS

This application in a continuation-in-part application which claimspriority from U.S. provisional patent application Ser. No. 61/107,511,filed on Oct. 22, 2008, U.S. provisional patent application Ser. No.61/159,143, filed on Mar. 11, 2009; and International Patent CooperationTreaty Application No. PCT/US08/53912, filed on Feb. 14, 2008, whichclaims priority from U.S. provisional patent application Ser. No.60/901,457, filed on Feb. 14, 2007; U.S. provisional patent applicationSer. No. 60/921,930, filed on Apr. 5, 2007; and U.S. provisional patentapplication Ser. No. 60/931,109, filed on May 21, 2007, the disclosuresof which are hereby incorporated herein by reference in theirentireties.

BACKGROUND OF THE INVENTION

The present invention is directed to a bariatric device and method ofcausing weight loss in a recipient.

Obesity is a large and increasing problem in the United States andworldwide. In round numbers, from the period encompassing the year 1990to the period encompassing the year 2000, the prevalence of overweightpeople (BMI greater than 25) increased from 56 percent of United Statesadults to 65 percent and the prevalence of obese adults (BMI greaterthan 30) increased from 23 percent to 30 percent. Likewise, theprevalence of overweight children and adolescents (ages 6-19 years)increased from 11 percent in the period encompassing the year 1990 to 16percent in the period encompassing the year 2000. The increasingprevalence of excess body mass among children and adolescents will makethe problem even greater when they reach adulthood. The problem is notlimited to the United States. Between 10 percent and 20 percent ofEuropean men are obese and between 10 percent and 25 percent of Europeanwomen are obese. Numerous medical conditions are made worse by obesityincluding Type II diabetes, stroke, gallbladder disease and variousforms of cancer. Approximately 500,000 people in North America andWestern Europe are estimated to die from obesity-related diseases everyyear and obesity is estimated to affect more than one billion adultsworldwide. Therefore, there is a pressing and unmet need for a solutionto the epidemic problem.

SUMMARY OF THE INVENTION

The present invention provides a bariatric device and method of causingweight loss in a recipient that fulfills this pressing and unmet need inan effective and minimally invasive manner. A bariatric device andmethod of causing weight loss in a recipient according to an aspect ofthe invention includes providing an esophageal member, a cardiac memberand a connector connected with the esophageal member and the cardiacmember. The esophageal member has an esophageal surface that isconfigured to generally conform to the shape and size of a portion ofthe esophagus. The cardiac member has a cardiac surface that isconfigured to generally conform to the shape and size of a portion ofthe cardiac portion of the stomach.

Receptors are stimulated in order to influence a neurohormonal mechanismin the recipient sufficient to cause weight loss including positioningthe esophageal surface at the esophagus and the cardiac surface at thecardiac portion of the stomach. This causes at least partial satiety byaugmenting fullness caused by food and simulating fullness in theabsence of food.

The connector may be positioned at the GE junction and be adapted toleave a contiguous portion of the GE junction substantiallyunrestrained. This contiguous portion of the GE junction may be at leasthalf of the GE junction, may be at least 75% of the GE junction and maybe at least 90% of the GE junction. The contiguous portion of the GEjunction may be at the angle of His.

The connector may include a tension member, such as a semi-rigid strap.The strap may be positioned within the GE junction opposite the angle ofHis. The strap may be made substantially of Nitinol.

The connector may include a tether. The tether may extend at leastpartially external the GE junction. The tether may be connected with theesophageal member and the cardiac member either in situ or external therecipient. The tether may be adjacent the angle of His. A clamp may beprovided to secure at least one end of the tether. The clamp may includea body and a plurality of through-openings in the body, thethrough-openings receiving the tether and allowing one-way movement ofthe body along the tether. In this manner, the body may be movable inone direction along the tether and resists movement in an oppositedirection.

The connector may include a plurality of the tethers. The tethers may bepositioned either on a same side of the GE junction or on opposite sidesof the GE junction. The tether(s) may be made from (i) substantiallynon-coated silk, (ii) Ethibond suture, (iii) ePTFE or (iv) an elasticmaterial. The tether(s) may include a tissue attachment surface or atissue ingrowth surface.

The esophageal member may have a reinforced tether attachment wallportion. The esophageal member may have an outer surface that defines atissue attachment portion. The esophageal member may include a cage andan impervious cover over the cage. The cage may be formed from anelongated member that is joined at junctions by ferrules. The cage maybe made up of an elongated member that is formed as an interwovenspiral. The cage may be covered with at least one flexible sleeve. Theelongated member may be a Nitinol wire. Distal and/or proximal endportions of the cage may be flared.

The cardiac member may include a generally planar member defining thecardiac surface. The planar member may include a through-opening adaptedto be positioned at the GE junction and a sealing flange surrounding thethrough-opening. The planar member may include a stiffening mesh and agenerally flexible material surrounding the mesh. The planar member mayinclude ribs that provide stiffening to the planar member or may includea surface feature to resist slippage of a deployment tool during tetherdriving. The cardiac member may be radiopaque in whole or in part.

The esophageal member, the cardiac member and the connector may bedefined by an elongated member that is at least partially spirallywound. A surface cover may be provided over at least the esophagealmember and the cardiac member. The connector may be defined by a portionof the elongated member that is not spirally wound.

The connector may be longitudinally adjustable. A ratchet mechanism maybe provided to provide the longitudinal adjustability to the connector.The ratchet mechanism may be adjustable in situ.

The connector may include an adjustable tether. The adjustable tethermay include a filament and a tube surrounding the filament to facilitatelengthwise movement of the filament.

The cardiac member may include a central portion and a surface extendingfrom the central portion. The surface may be compressible toward itselffor deployment and biased away from itself. The surface may be definedby lobes that are formed from elongated members.

The bariatric device may be deployed transorally. Manipulation lines mayextend from the esophageal member and/or the cardiac member external therecipient to assist in deployment.

The bariatric device may be substantially non-restrictive to foodpassage.

The amount of stimulation to the receptors may be adjustable, such as byadjusting the connector and/or by selecting the bariatric device fromamong a plurality of bariatric devices of different sizes.

A unidirectional clamp and method of endoluminally restraining an end ofa medical filament includes providing a body having at least threeopenings in body. An end portion of the filament is passed through twoof the at least three openings to form a loop in the filament. Afilament end is passed through another of the opening and under theloop.

A bariatric device and method of causing weight loss in a recipient,according to another aspect of the invention, includes providing atleast one cardiac member that is configured to stimulate receptors at aportion of the cardiac region of the stomach. An anchor is provided toengage the cardiac region of the stomach to anchor the at least onecardiac member. In this manner, the cardiac member is capable ofinfluencing a neurohormonal mechanism in the recipient.

The at least one cardiac member may define a cardiac surface and theanchor may hold the cardiac surface against the cardiac region of thestomach.

The anchor may be a plurality of anchors that are distributed about thecardiac region of the stomach with the at least one cardiac memberapplying a force between adjacent ones of the anchors. The at least onecardiac device may be an endless band that applies a contraction forceto the plurality of anchors. Alternatively, the at least one cardiacdevice may be expansion devices, such as expansion springs, that applyan expansion force between adjacent ones of the anchors.

The anchor may include a surface that facilitates tissue attachmentand/or tissue ingrowth.

The cardiac member may be configured to the size and shape of thecardiac region of a recipient with altered anatomy, such as a recipientwho has undergone a gastric bypass procedure, a vertical bandedgastroplasty, a sleeve gastrorectomy, a duodenal switch, or the like.

These and other objects, advantages and features of this invention willbecome apparent upon review of the following specification inconjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front elevation of a bariatric device deployed in arecipient;

FIG. 2 is an illustration of a recipient's gastroesophageal (GE)junction in a dilated state with a bariatric device in place;

FIG. 3 is the same view as FIG. 2 with the GE junction in a constrictedstate;

FIG. 4 is a perspective view of the bariatric device in FIG. 1 prior todeployment;

FIG. 5 is a perspective view of the bariatric device in FIG. 1 asdeployed in a recipient as viewed from the angle of His;

FIG. 6 is a rear elevation of the bariatric device in FIG. 1;

FIG. 7 is a proximal view of the bariatric device in FIG. 1;

FIG. 8 is a distal view of the bariatric device in FIG. 1;

FIG. 9 is another distal view of the bariatric device in FIG. 1;

FIG. 10 is an elevation of an esophageal member;

FIG. 11 is a perspective view of an outer sleeve of the esophagealmember in FIG. 10;

FIG. 12 is a perspective view of an inner sleeve of the esophagealmember in FIG. 10;

FIG. 13 is a perspective view of a tension member;

FIG. 13 a is the same view as FIG. 13 of an alternative embodimentthereof;

FIG. 14 is a perspective view of a cardiac member;

FIGS. 15 a and 15 b are a flowchart of a procedure for deployment of abariatric device;

FIGS. 16 a and 16 b are a flowchart of an alternative procedure fordeployment of a bariatric device;

FIG. 17 is a perspective view of a bariatric device deployment member;

FIG. 18 is a perspective view of a medical device fixation tool fixing abariatric device;

FIG. 19 is an elevation of the medical device fixation tool fixing thebariatric device in FIG. 18;

FIG. 20 is an elevation of a tether clamp;

FIG. 21 is the same view as FIG. 19 illustrated with a tether;

FIG. 22 is an enlarged perspective view of the tether clamp device ofFIGS. 19 and 20;

FIG. 23 is a perspective view of an alternative embodiment of abariatric device deployed in a recipient;

FIG. 24 is a perspective view of the bariatric device illustrated inFIG. 23 taken from a side and distal direction;

FIG. 25 is a perspective view of the bariatric device in FIG. 23illustrating additional detail thereof;

FIG. 26 is a perspective view of the bariatric device in FIGS. 22through 24 illustrating additional details thereof;

FIG. 27 is an elevation of an esophageal member of the bariatric devicein FIG. 23;

FIG. 28 is the same view as FIG. 27 of an alternative embodiment of anesophageal member;

FIG. 29 is a perspective view of a cage structure used in the esophagealmember in FIG. 27;

FIG. 30 is the same view as FIG. 29 of an alternative embodiment of anesophageal member cage structure;

FIG. 31 is a perspective view of an alternative embodiment of a tether;

FIG. 32 is a perspective view of an alternative embodiment of abariatric device;

FIG. 33 is an elevation of a connector used with the bariatric device ofFIG. 32;

FIG. 34 is the same view as FIG. 33 of an alternative embodimentthereof;

FIG. 35 is the same view as FIG. 33 of another alternative embodimentthereof;

FIG. 36 is the same view as FIG. 33 of yet another alternativeembodiment thereof;

FIG. 37 is the same view as FIG. 33 of yet another alternativeembodiment thereof;

FIG. 38 is a perspective view of another alternative embodiment of abariatric device;

FIG. 39 is a perspective view of another alternative embodiment of abariatric device;

FIG. 40 is a perspective view of another alternative embodiment of abariatric device;

FIG. 41 a perspective view of another alternative embodiment of abariatric device;

FIG. 42 is a perspective view of another alternative embodiment of abariatric device;

FIG. 43 is an enlarged view of a portion of the bariatric device in FIG.42;

FIG. 44 is a perspective view of another alternative embodiment of abariatric device;

FIG. 45 a perspective view of the cardiac member of the bariatric devicein FIG. 44;

FIG. 46 a perspective view of another alternative embodiment of abariatric device;

FIG. 47 is a perspective view of another alternative embodiment of abariatric device;

FIG. 48 is the same view as FIG. 47 including an outer surface cover forthe cardiac member;

FIG. 49 is a perspective view of another alternative embodiment of abariatric device;

FIG. 50 is a perspective view of another alternative embodiment of abariatric device;

FIG. 51 is a perspective view of another alternative embodiment of abariatric device;

FIG. 52 is a perspective view illustrating deployment of the bariatricdevice of FIG. 51;

FIG. 53 is a perspective view of an alternative embodiment of abariatric device;

FIG. 54 is a perspective view of deployment of the bariatric deviceillustrated in FIG. 53;

FIG. 55 is a perspective view of an alternative embodiment of anesophageal member;

FIG. 56 is a perspective view of another alternative embodiment of anesophageal member;

FIG. 57 is a perspective view of an alternative embodiment of a cardiacmember;

FIG. 58 is a perspective view of another alternative embodiment of acardiac member;

FIG. 59 is a perspective view of another alternative embodiment of abariatric device;

FIG. 60 is a perspective view of the bariatric device of FIG. 59;

FIG. 61 is a distal view of another alternative embodiment of abariatric device;

FIG. 62 is the same view as FIG. 61 of another alternative embodiment ofa bariatric device;

FIG. 63 is an elevation of a stud used in FIGS. 62 and 63;

FIG. 64 is the same view as FIG. 63 illustrating installation of thestud;

FIG. 65 is a perspective view of another alternative embodiment of abariatric device;

FIG. 66 is another perspective view of the bariatric device of FIG. 65;

FIG. 67 is an enlarged perspective view of the esophageal member of thebariatric device of FIG. 65;

FIG. 68 is an enlarged perspective view of the cardiac member of thebariatric device of FIG. 65;

FIG. 69 is an enlarged perspective view of an esophageal member ofanother alternative embodiment of a bariatric device;

FIG. 70 is an enlarged perspective view of the cardiac member of thebariatric device of FIG. 69;

FIG. 71 is a perspective view illustrating deployment of anotheralternative embodiment of a bariatric device deployed in a recipientthat underwent a vertical banded gastroplasty;

FIG. 72 is a perspective view illustrating deployment of anotheralternative embodiment of a bariatric device deployed in a recipientthat underwent a sleeve gastrorectomy;

FIG. 73 is a perspective view illustrating deployment of anotheralternative embodiment of a bariatric device deployed in a recipientthat underwent a duodenal switch; and

FIG. 74 is a perspective view illustrating deployment of anotheralternative embodiment of a bariatric device deployed in a recipientthat underwent a gastric bypass procedure.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now specifically to the drawings, and the illustrativeembodiments depicted therein, a bariatric device, such as an endoluminalbariatric device 10 includes an esophageal member 12, a cardiac member14, and a connector 16 that is connected with esophageal member 12 andcardiac member 14 (FIGS. 1-14). Esophageal member 12 has a wall 18defining an esophageal surface 20 that is configured to generallyconform to the shape and size of a portion of the esophagus, namely, atthe abdominal portion of the esophagus adjacent the gastroesophageal(GE) junction. While illustrated as cylindrical in shape, wall 18 may beother shapes, such as a portion of a cylinder, or the like. Cardiacmember 14 includes a body 21 defining a cardiac surface 22 that isconfigured to generally conform to the shape and size of at least aportion of the cardiac portion of the stomach. Connector 16, which isillustrated as a system of connector members, joins the esophageal andcardiac members. Connector 16 may include a tension member 24 which maybe a semi-rigid strap which passes through the GE junction. Connector 16may include one or more tethers 26 which may be attached to theesophageal and cardiac members and pass from the esophageal member tothe cardiac member outside of the GE junction. As will be described inmore detail below, this is accomplished by passing tether 26 throughwall 18 of esophageal member 12 through the wall of the esophagus,through the wall of the stomach at the cardiac region, and through body21 of the cardiac member.

In the illustrated embodiments, connector 16 leaves most of the GEjunction unrestrained. As best seen by comparing FIGS. 2 and 3, tensionmember 24 may be positioned opposite the angle of His. The portion ofthe pseudo-sphincter of the GE junction at the angle of His isrelatively unrestrained by the connector and can constrict against theremainder of the pseudo-sphincter and tension member 24 as best seen inFIG. 3. Tension member 24 may include an inwardly curved portion 28 thatallows the portion of the GE junction pseudo-sphincter opposite theangle of His to assume a relatively normal posture, again as illustratedin FIGS. 2 and 3. As best illustrated in FIG. 1, tether(s) 26 passesoutside of the GE junction pseudo-sphincter through the walls of theesophagus and stomach. Once again, the pseudo-sphincter of the GEjunction is allowed to constrict in a relatively unrestrained mannerbecause the tether(s) do not significantly interfere with thepseudo-sphincter of the GE junction. Thus, connector 16 allows the GEjunction to dilate for the passage of food (FIG. 2) and constrict whenfood is not passing (FIG. 3) in order to resist passage of stomachcontents into the esophagus. Also, the GE junction pseudo-sphincter isallowed to function in a relatively normal manner for the purposes ofbelching, vomiting, and the like.

In the illustrated embodiment, most of the GE junction pseudo-sphincteris allowed to operate without substantial restraint. Indeed, at least 75percent, and even 90 percent, of the GE junction may be unrestrained inorder to function in a relatively normal fashion. In the illustrativeembodiment, tension member 24 is made of 0.014 inch super-elasticNitinol sheet. Because the tension member is in the form of a relativelythin semi-flexible strap, it is able to be folded back for the purposeof inserting the bariatric device through the esophagus for deployment,in a manner that will be described in more detail below. Tether(s) 26may be an elongated filament, such as an uncoated silk suture, anEthibond suture, an ePTFE suture, an elastic line, or the like. As willbe described in more detail below, if desired, tether(s) 26 may bewithin a sheath to allow the filament to move lengthwise, for example,to facilitate subsequent adjustment of the spacing between theesophageal and cardiac members to adjust the degree of satiety. Anuncoated silk suture may produce fibrous tissue, which may preventlateral drift of the tether through the tissue at the GE junction.Alternatively, a tether 126 may be used having a surface that promotestissue attachment and/or tissue ingrowth (FIG. 31) to prevent lateraldrift of the tether.

As will be described in more detail below, connector 16 may be generallyin tension and cardiac surface 22 stimulates mechanoreceptors in thecardiac region of the recipient in order to influence a neurohormonalfeedback mechanism of the recipient sufficient to cause the recipient tolose weight. While the precise manner of causing this effect is notcompletely known, it may result from an increase in the metabolic rateof the recipient and may cause at least partial satiety by augmentingfullness caused by food and simulating fullness in the absence of food,as described in commonly assigned International Publication No. WO2006/044640 A1 entitled BARIATRIC DEVICE AND METHOD, the disclosure ofwhich is hereby incorporated herein by reference in its entirety. Asdescribed in WO '640, this may be accomplished without mechanicallyrestricting the food intake, such as by inserting a restriction deviceat the esophagus, GE junction, or the like, utilized in prior artbariatric devices. Esophageal surface 20 may additionally contribute tosatiety and/or increase in metabolic rate, but its primary function isto work in collaboration with connector 16 and cardiac member 14 toresist distal migration of bariatric device 10. Also, connector 16,particularly tension member 24, may apply pressure at a portion of theGE junction and, thereby, assist in generating satiety.

As previously described, cardiac surface 22 of cardiac member 14 and theesophageal surface of the esophageal member are configured to stimulatemechanoreceptors at the abdominal portion of the esophagus, theesophageal-gastric junction and/or the cardia of the recipient. Themechanoreceptors stimulated may be tension receptors, which aresensitive to contraction and elongation; stretch receptors, which aresensitive to elongation only; and/or baroreceptors, which are stimulatedby change in pressure. This stimulation may be accomplished by cardiacsurface 22 and esophageal surface 20 exerting a strain, such as anoutward pressure, typically a generally radial outward pressure, to thewall of the cardiac region of the stomach and the abdominal portion ofthe esophagus. This may be accomplished, at least in part, by theconnector 16 transmitting forces between the esophageal member and thecardiac member to press cardiac surface 22 against the cardia. It mayalso be accomplished, at least in part, by configuring the wall of theesophageal member to create an interference fit with the abdominalportion of the esophagus. The bariatric device may, alternatively, applyan inward force on the abdominal portion of the abdominal portion of theesophagus, the esophageal-gastric junction and/or cardia. The bariatricdevice may, alternatively, apply a longitudinal force, such as aproximal/distal force, to the abdominal portion of the esophagus, theesophageal-gastric junction and/or the cardia.

The strain exerted by the bariatric device influences receptors of theneurohormonal feedback mechanism of the neurohormonal system, also knownas the neuroendocrine system, present at the esophagus and/or stomach tocause weight loss. The strain that influences the neurohormonal feedbackmechanism present at the abdominal portion of the esophagus, theesophageal-gastric junction and/or the cardiac portion of the stomach isintended to be relatively consistent over as large an area as reasonablypossible. In contrast to prior proposed devices, such as restrictiondevices, which require that the recipient ingest food in order toinfluence neurohormonal feedback mechanisms, the embodiments of thebariatric devices disclosed herein is effective in the absence of food.It also augments fullness caused by food.

Tension member 24 interconnects the esophageal and cardiac members, aspreviously described, and may also serve as a location for fastening ofthe bariatric device, such as to the muscularis at the GE junction, suchas by using conventional sutures passed around the strap or byspecialized clips (not shown) that can be deployed in situ to connectthe strap with the recipient. Tether(s) 26 serves to resist distalmigration because the tether passes through the esophageal wall and thestomach wall and creates a sort of sandwiching of the esophageal walland the stomach wall between esophageal surface 20 and cardiac surface22. This is due, in part, to the upward extension of the cardia at theangle of His to be somewhat parallel to the esophageal wall. Connector16 also serves to bring cardiac surface 22 into engagement with thecardia in order to stimulate the neuroreceptors, which are dominant inthe cardia. Thus, it is seen that esophageal member 12, cardiac member14, and connector 16 all operate in unison to resist distal migration ofbariatric device 10 while causing satiety and thereby weight loss in therecipient.

Cardiac member 14 may be made of a generally resilient material havingsufficient flexibility to allow it to be compacted to pass through theesophagus while having sufficient rigidity to allow it to transmitstrain from connector 16 to the cardiac region of the stomach. In theillustrated embodiment, body 21 of cardiac member 14 is made from amolded silicone, such as 60 durometer LSR silicone with an embedded meshsuch as a fabric mesh 23 of the type that is known in the art, such as aprecision woven polypropylene 35.5×35.5 mesh. The mesh increases tearresistance and stiffness. Body 21 may include a proximally raisedportion 34 defining a flange. Flange 34 is configured to fit against theGE junction. This causes food to be directed through opening 36 in body21 while resisting the food passing between cardiac surface 22 and thewall of the stomach. In the illustrated embodiment, cardiac member 14may be configured to apply a nominal strain on an order of magnitude of6.5 PSI to the cardia, although the actual pressure may vary dependingon installation factors, such as tension on the tether(s), or the like.In the illustrated embodiments, cardiac member 14 is configured toengage the cardia and not the fundus of the stomach. The cardia isresistant to dilation due to its structure while the fundus is subjectto dilation. Therefore, cardiac member 14 stimulates themechanoreceptors without causing substantial dilation.

Tension member 24 may pass through opening 36 and has an extension 38that fastens to body 21 of the cardiac member opposite cardiac surface22, such as by suture material 35 (FIG. 13). Grooves 37 may be providedto stabilize the suture material. Extension 38 may also be attached tobody 21 by being inset molded, and/or using fasteners, or the like.Tension member 24 additionally includes a proximal extension 40 thatattaches to wall 18 of esophageal member 12 using similar techniques. Analternative embodiment of a tension member 24′ is illustrated asincluding an adjustment mechanism 39 (FIG. 13 a). Adjustment mechanism39 may adjust either the relative angle between extension 38 andproximal extension 40 or may adjust the length of extension 38 relativeto proximal extension 40. Adjustment mechanism 39 may be operable by aphysician transorally to adjust the orientation of cardiac member 21with respect to esophageal member 12. This allows the bariatric deviceto conform to the recipient's anatomy and to apply a desired pressure tothe cardiac region of the stomach. Alternatively, adjustment mechanism39 may be adjusted by a control of the type disclosed in InternationalPublication No. WO 2006/044640 A1 entitled BARIATRIC DEVICE AND METHOD,the disclosure of which is hereby incorporated herein by reference inits entirety.

Tether 26 may be held in place proximately by a tether clamp, such as abutton 98, on an interior surface of wall 18 of esophageal member 12 andmay be held in place distally by a tether clamp, such as a T-fastener,against a surface of body 21 opposite cardiac surface 22. In theillustrated embodiment, a T-fastener 42 is attached to the distal and ofeach tether and is passed through esophageal wall 18 and cardiac memberbody 21 utilizing a medical device fixation tool, or tether device, 86.Tether device 86 is described in detail in commonly assignedInternational Patent Application No. PCT/US2008/053962, filed on Feb.14, 2008, entitled MEDICAL DEVICE FIXATION TOOL AND METHOD OF FIXATIONOF A MEDICAL DEVICE, and in U.S. provisional patent application Ser. No.60/901,457 filed on Feb. 14, 2007, and U.S. provisional patentapplication Ser. No. 60/921,930, filed on Apr. 5, 2007, entitledBARIATRIC DEVICE AND METHOD, the disclosures of which are herebyincorporated herein by reference in their entirety. Suffice it to saythat tether device 86 may include a cardiac support 90 that ispositioned by a shaft 110 within the recipient's stomach. Cardiacsupport 90 may be pivoted between a deployment position aligned withshaft 110 and a use position supporting the cardiac member 21 by anactuator (not shown) as illustrated in FIGS. 18 and 19. A needle firingactuator, or needle driver, 122 is capable of propelling a needlecarrying T-fastener 42 through wall 18 through cardiac member body 21and through an opening 128 in cardiac support 90. Alternatively,T-fastener 42 can have a pointed end and be driven directly by needledriver 122 through wall 18 and body 21. Once T-fastener 42 is throughthe cardiac member, proximal tension on tether 26 will seat T-fastener42 and pull cardiac surface 22 against the cardia of the recipient.

Body 21 may be formed with a series of openings 41 at a portion of thebody that is opposite from tension member 24. The needle driver 122 ofthe tether device may align with one of openings 41 thereby easing thepassage of the tether through body 21. However, the nature of thematerial making up body 21 would accommodate passage of the tetherwithout openings 21. One or more radiopaque surfaces 43 may be providedopposite tension member 24 or the entire body 21 could be radiopaque.These allow the physician to visualize the angle of cardiac surface 22using fluoroscopy to assist in placement of the bariatric device in therecipient. Also, the angle between cardiac surface 22 and esophagealmember 12 can be visualized if the esophageal member has any metallic orother radiopaque component. This allows the physician to determine ifthe cardiac surface and esophageal member are too close together, whichcould risk the bariatric device migrating, or too far apart, which couldproduce insufficient satiety. Also, a surface feature, such as anindentation and/or raised shoulders, could be formed on body 21 oppositecardiac surface 22 that conforms to support 90 to assist in maintainingalignment between support 90 and body 21 during driving of the needlethrough body 21.

Alternatively, a bariatric device 10′ may be provided in which tetherclamps in the form of buttons 98 are applied to tether(s) 26 afterneedles attached to tether(s) 26 passes through walls 18 and 21 and therecipient's esophageal wall and stomach wall in a manner that will beexplained in more detail below (FIGS. 23-26).

Esophageal member 12 may include a cage 44, and an impervious wall 45covering cage 44. Wall 45 may be provided by an inner sleeve 46, and anouter sleeve 48 covering cage 44 (FIGS. 10-12). A pad 47 made from atissue attachment or tissue ingrowth material may be provided onesophageal member 12 where the tethers enter the esophagus to long-termattachment. Pad 47 may be made of a polypropylene mesh. Cage 44 may bemade from an elongated member 50, which, in the illustrated embodiment,is an elastic member, such as Nitinol wire. Member 50 is formed as aninterwoven spiral, as illustrated in FIG. 10. Alternatively, esophagealmember 12 may utilize a cage 144 in which the elongated member is formedas a lattice and joined at adjacent points, such as by ferrules 52(FIGS. 27-29). Distal ends 54 of elongated members 50 may form distaltines 54 to resist distal migration of esophageal member 12. Esophagealmember 12 may be outwardly flared proximally, in order to ensure contactwith the esophageal wall, and may be outwardly flared distally in orderto assist the engagement of tines 54 at the wall of the organ, such asthe thick musculara adjacent the GE junction. Tines 54 may be slightlyoutwardly extending in order to ensure penetration of the organ wall. Inthe illustrated embodiment, tines 54 have a length of approximately 1.5mm.

An alternative embodiment of a cage 44′ is made from an elongated member50′ that is formed into the three-dimensional structure without therequirement for separate ferrules to join adjacent portions of thestructure (FIG. 30). This is accomplished by inter-looping the elongatedmember at adjacent portions, as illustrated at 52′. In the embodimentillustrated in FIG. 29, cage 44′ does not include tines at a distal endportion thereof. Other embodiments will be apparent to the skilledartisan. For example, a circumferential ring (not shown) may be providedat a proximal portion of cage 44, 44′ in order to provide for thetransfer of axial forces around the perimeter of the cage. This may beuseful, for example, in order to provide a grasping member should it bedesired to remove the bariatric device, reposition the esophagealmember, or the like. Due to the structure of cage 44, 44′, a proximalforce placed upon a proximal end thereof should result in a reduction indiameter in the cage that would allow the cage to be pulled into anovertube of the type that is known in the art. Once in the overtube, theesophageal member could be rotated or repositioned proximally ordistally or the bariatric device removed. An alternative embodiment of acage 144′ includes a portion of elongated member 50 that is loopeddistally to define a tether attachment portion of wall 18. The purposeof loop 50 is to provide reinforcement to wall 18 to support attachmentof the tether(s).

Esophageal member 12 may include an inner sleeve 46 and an outer sleeve48 over cage 44, 144, 144′ (FIGS. 11 and 12) defining wall 18. Eachsleeve in the illustrated embodiment may be made of 0.005 thickness ofsilicone and may include an outer taper 56 proximally and/or distally inorder to conform to the shape of cage 44, 44′. With inner sleeve 46 andouter sleeve 48 positioned over the cage, the sleeves may be joined. Theinner and outer sleeves may be fused, or laminated, at all points wherepossible within the openings of the cage. In an alternative embodiment,inner and outer sleeves 46, 48 may be fused at smaller fusion areaswhich are smaller than the respective opening in the cage. This may beaccomplished, by way of example, by forming an opening at correspondingportions of the inner and outer sleeves and fusing the sleeves at thatarea, such as by the use of a biologically compatible adhesive, such asa silicone adhesive, or the like. The amount of fusion, or lamination,may affect the amount of rigidity of the esophageal member in resistinglateral forces. This may be used, in combination with the structure ofthe cage and the diameter of the elongated member 50 to adjust theamount of strain placed by the esophageal member on the esophagus by theesophageal member. Although illustrated as made from Nitinol wire,esophageal, the cage may be made from other material, such as apolyetheretherkeytone polymer (PEEK), carbon fiber filament, or thelike.

In the illustrated embodiment, esophageal member 12 is between 1.8 cmand 2.1 cm inner diameter with 2.2 cm flare at the proximal end portion.It may have a length of between 2 cm to 3 cm or more if needed foranchoring. However, a shorter length tends to reduce the likelihood offood forming an obstruction in the esophageal member. It should beunderstood that size may vary as a function of the size and anatomy ofthe recipient. Esophageal member 12 and/or cardiac member 14 may beaffixed in whole or in part using the mucosal capture techniquedisclosed in commonly assigned International Application No.PCT/US08/53797 filed on Feb. 13, 2008, entitled MUCOSAL CAPTURE FIXATIONOF MEDICAL DEVICE, the disclosure of which is hereby incorporated hereinby reference in its entirety.

A bariatric device deployment procedure 70 may be used to deploybariatric device 10 (FIGS. 15 a and 15 b). Deployment procedure 70begins at 71, with the recipient sedated or anesthetized, by performingan esophageal gastroduodenoscopy (EGD) to inspect the recipient'sesophagus and stomach and to pass a conventional EGD wire through an EGDscope into the stomach (72). The physician may inject contrast die atone side of the GE junction in order to assist in fluoroscopicvisualization and the placement of the bariatric device. The EGD scopeis removed and the wire is left in the recipient's esophagus.

The wire may be used to pass a lubricated deployment device 74, as seenin FIG. 17, into the stomach utilizing fluoroscopy (73). The wire may beremoved. The cardiac member is deployed distally at 75 utilizing apusher inserted within deployment device 74. Because of the nature ofthe cardiac member, it will unfold once it is clear of the deploymentdevice. The physician can use a marker 68 on the deployment device toalign the bariatric device by rotation of the device until marker 68 isappropriately positioned. Alternately, the physician could rotate thedevice until tension member 24 either aligns with or is opposite thecontrast die mark. With the cardiac device deployed in the stomach, thephysician pulls back on the deployment device 74, which pulls thecardiac member against the cardia and deploys the esophageal member fromthe deployment device. The deployment device is then removed from therecipient (75).

A conventional overtube may be positioned over a conventional endoscopeand deployed in the recipient's esophagus distally to the proximal endof esophageal member 12 (76). The overtube provides a pathway to thebariatric device to allow completion of deployment while minimizing riskof damage to the recipient's esophagus.

A tether assist device 86 (FIGS. 18 and 19) may be inserted through theovertube at 78. The tether assist device includes a cardiac support 90that is deployed in a manner which will be described in more detailbelow (79). The tether assist device is actuated to drive needlesconnected with the tether filament through the wall 18 of the esophagealmember, the wall of the recipient's esophagus, the wall of therecipient's stomach at the cardia, and body 21 of the cardiac member(80). The cardiac support is then retracted and the tether assist deviceis withdrawn at 81.

The distal end(s) of the tether filament(s) may be secured against thesurface of cardiac member body 21 opposite the cardiac surface 22 byapplying a proximal force to the tether until integral tether clamp 42is against body 21 of the cardiac member. If a separate distal tetherclamp is applied in situ, this may be accomplished by inserting anendoscope E through the overtube and through the esophageal member intothe recipient's stomach to grasp and withdraw the tether end(s) externalto the recipient (82). Alternatively, tether assist device 86 may retainthe tether distal end(s) with the cardiac support so that withdrawal ofthe tether assist device also withdraws the tether end(s) external tothe recipient. A tether clamp, such as a button 98, (FIGS. 23 and 25)may be fixed to the distal end of the tether filament(s) and theproximal end of the tether filament(s) pulled in order to position thetether clamp against the cardiac member (82). Another tether clamp, suchas a button 98 may be attached to the proximal end of the tether(s),such as by a slipknot, as will be described in more detail below, andthe clamp slid against the wall of the esophageal member, such as byusing a knot pusher (83). The knot pusher may have a tapered end toensure that the button may be pushed entirely against the wall of theesophageal member. Optionally, if more than one tether filament is used,the physician may tie the proximal ends of the tether filaments togetherand, using a knot pusher, slide the knot against the tether clamp at theesophagus. Excess tether filament may be trimmed and the overtubewithdrawn at 84.

In an alternative embodiment (FIGS. 16 a and 16 b), in which thetether(s) is positioned in the recipient before the bariatric device isdeployed, a bariatric device deployment procedure 88 begins with an EGDbeing performed (89) and an overtube being positioned over an endoscopeand deployed to the proximal to the GE junction (91). The tether assistdevice is inserted through the overtube (92) and operated to deploy thecardiac support (93). The tether assist device is then operated at 94 todrive the needle(s) through the walls of the esophagus and the cardia.The tether assist actuator is operated at 95 to retract the cardiacsupport and to withdraw the tether assist device.

The tether needle(s) are withdrawn through the overtube to a locationexternal the recipient (96). The bariatric device may be affixed to bothends of the tether(s). In particular, the proximal end of the tethersare inserted through openings in the esophageal member. The distal endsof the tether(s) are passed through the cardiac member and affixed tothe cardiac member, such as using a button 98 as previously described.The bariatric device may then be positioned in the deployment device at97 and the wire is used to pass the deployment device into the stomachwith fluoroscopic assist. While the bariatric device is being deployedto the stomach, the physician takes up slack in the tether(s) by pullingon the proximal ends thereof.

The cardiac member is deployed (99) and the esophageal member isdeployed (100) in a manner similar to that previously described. Whenslack is removed from the tether(s), the physician may attach a buttonto the proximal end of the tether(s) at 101 and slides the button(s)against the wall of the esophageal member, such as using a knot pusher.Appropriate tension is applied. If more than one tether is used, thephysician may optionally tie the proximal ends together and slide theknot against the esophageal button. The esophageal member may then beanchored (102), as previously described, and excess tether materialtrimmed (103). Although two (2) tethers are illustrated, one or morethan two may be used. If more than two tethers are used, they can beattached to the esophageal member and the cardiac member in a mannerthat distributes the force both laterally and longitudinally on eachmember.

Thus, it is seen that bariatric device deployment procedure 70, 88 isminimally invasive and can be performed transorally utilizing many toolsthat are conventionally used for EGD and endoscopy. The deploymentprocedure can be performed in a relatively short time, on the order ofmagnitude of the time required for an endoscopy, colonoscopy, or thelike, such as less than one hour and even less than half an hour orless. Because the recipient is sedated, or minimally anesthetized, therecipient should tolerate the procedure much better than a more invasiveprocedure, such as gastric bypass surgery or other bariatric surgery. Itshould be understood, however, that bariatric device 10 can be deployedutilizing other techniques. For example, tethers 26 can be deployedutilizing a combination of laparoscopic and endoscopic procedurescarried out with conventional instruments, rather than utilizing thetether assist device disclosed herein.

Deployment device 74 includes a tubular member 106 which may have a wallmade of 1/32 inch PTFE with a cross section that is smaller than therecipient's esophagus, such as 11/16 inch outer diameter, and having atapered distal end 108 to reduce a tendency to snare the esophagus whilebeing inserted (FIG. 17). Bariatric device 10 may be folded with cardiacmember 14 rolled and esophageal member 12 radially compressed. Tensionmember 24 may be flexed to position the esophageal and cardiac membersin the deployment device in the position illustrated in FIG. 11. Aballoon 69 may be inserted in the deployment device and inflated tofurther enhance the smooth contours of the delivery system. Duringdeployment, tubular member 106 is lubricated and, as previouslydescribed, inserted into the stomach over a previously placed wire andguided using fluoroscopy. Once in position, balloon 69 can be deflatedand the cardiac member may be deployed by an instrument inserted intothe proximal end of the tubular member until the cardiac member exitsthe tube, at which time it will unravel to its deployed position. Withthe physician moving the deployment device proximally, the cardiacsurface 22 will be moved into contact with the cardia and the esophagealmember will begin to be deployed out the distal end of tubular member106. Further proximal motion of the tubular member will fully deploy theesophageal member in the esophagus. Should it be desired to repositionthe bariatric device, the physician can insert an overtube into theesophagus in a conventional manner, such as over an endoscope, and graspa proximal end of cage 44, 144, 144′ in order to reduce the diameter ofthe cage and position the overtube over the esophageal member 12. Thebariatric device can then be rotated or, otherwise, moved and redeployedout of the end of the overtube.

Other deployment devices may be utilized. For example, rather than beingconfined within a tubular deployment tool, the bariatric deviceesophageal member and cardiac member may be compressed and retained in acompressed state by a cord wound around the members. Once in position,the cord can be removed from around each of the members by pulling on acord to deploy that member, which then assumes its expanded state.Alternatively, the bariatric device members could be compressed at theirrespective positions on the tether assist device, with the cardiacmember compressed about cardiac support 93 and the esophageal membercompressed about the shaft of the tether assist device. In this manner,both the bariatric device and the tether assist device can be deployedsimultaneously through an over-tube and the bariatric device expanded inthe proper orientation to the tether assist device by pulling on thecord. This allows the physician to orient the bariatric device in therecipient by orienting the tether assist device.

One or more lines 66 a, 66 b, may be attached to the esophageal memberand extend proximally outside the recipient to allow the physician tosnug the bariatric device against the cardiac portion of the stomach.Another line 66 c may be attached to cardiac member 21 and extendproximally through the esophageal member external the recipient. Line 66c allows the physician to position cardiac member 21 laterally and tohold it in place while the tethers are being applied. Lines 66 a-66 bmay be made from sutures and may be color-coded. Once bariatric device10 is fully deployed, lines 66 a, 66 b are severed at the device usingendoscopic scissors, or the like.

While the tether clamp for the distal end of the tether(s) can besecured to the tether(s) external the recipient and drawn into positionagainst the cardiac member or can be a fastener integrally formed withthe distal end of the tether and driven to position by the tether tool,the proximal end of the tether(s) may be secured by a tether clamp 98external the recipient and slid into engagement with the inner wall ofthe esophageal member along the tether filament once the bariatricdevice is deployed.

In the illustrative embodiment, the tether clamp may be a button 98 inthe form of a disk 130 containing a plurality, such as three (3),through-openings 132. Disk 130 may be made of a suitable material, suchas polycarbonate, or the like. As illustrated in FIGS. 21 and 22, tetherclamp 98 is attached to the proximal end of the tether by passing an end26 a of the tether under a loop 26 b formed by the tether therebyforming a one-way clamp that operates similarly to a slipknot. Thisallows the tether clamp to be propelled along the tether from externalthe recipient to a position engaging the inner wall of the esophagealmember and snugged up to a desired tension of the tether, using aconventional knot pusher, or the like. Although the tether clamp canmove relatively freely in one direction for deployment, it resistsmovement in the other direction, thereby firmly engaging the inner wallof the esophageal member or cardiac member. A roughened portion 133 ofthe surface 131 of disk 130 may be provided to help lock the tether toresist movement of tether clamp 98. also, an elongated extension ofsurface 131 (not shown) may be provided on either side of opening 132 totrap or pinch the end 26 a of the tether. Tether clamp 98 causes tensionbetween the esophageal member and the cardiac member via the tether,thereby both engaging the cardiac surface with the cardiac region of thestomach in order to activate receptors in the cardia, as well as toassist in anchoring bariatric device 10 in place. For additionalstability, the physician may choose to tie a slipknot to the ends, ifmore than one tether is used, and slide the slipknot against the buttons98 within the esophageal member using a knot pusher. The ends of thetether are trimmed and removed. The overtube can then be removed.

Once deployed, bariatric device 10 may be removed by inserting aconventional overtube in the esophagus and using endoscopic scissors,laparoscopic scissors, or the like, to clip the tether(s). The proximalportion of the esophageal member may be grasped, such as with aconventional grasping tool and pulled proximally. This reduces thediameter of the esophageal member allowing the esophageal member to fitwithin an overtube. The overtube may be moved distally around theesophageal member, thereby protecting the esophagus and GE junction asthe remainder of the bariatric device is retrieved through the overtube.The entire overtube may then be removed, completing the removalprocedure. If tissue apposition is used, a conventional ablationprocedure may be used to remove the ingrown tissue, such as mucosa, toallow the bariatric device to be moved. Alternatively, bariatric device10 may be made from bioabsorbable material and absorbed in therecipient's body.

Because of the use of the tether(s) and tissue ingrowth for anchoring,bariatric device 10 may be left in place for many months and even a yearor longer. Because bariatric device 10 can be deployed for longer thanjust a few weeks, morbidly obese recipients can use bariatric device 10to lose all or most of their excess bodyweight. The recipient may beprovided with nutritional counseling in order to develop healthiereating habits during the period of satiety induced by bariatric device10. Tension on the tether(s) and/or tension may be adjusted afterdeployment as needed to titrate the amount and rate of weight loss.Tension on the tether may be increased by sliding button 98 whilegrasping the tether or may be reduced by loosening or replacing thetether. As with any weight loss regiment, recipient's medications shouldbe adjusted to account for the weight loss.

Although illustrated for use in deployment of bariatric device 10,tether clamps 98 may find other applications. Examples of such otherapplications include closure of fistulas, tightening of anastomosis,closure of leaks, tightening of a gastric pouch and closure of agastrotomy. Other applications will be apparent to the skilled artisan.

An alternative embodiment of a bariatric device 10′ includes anesophageal member 12′ having a conically shaped proximal portion and acardiac member 14′ (FIGS. 23-26). Bariatric device 10′ includes aconnector 16′ made up of a tension member 24 and a plurality of tethers26. Tethers 26 are radially spaced apart in order to provide additionalupward pressure on the cardiac member. Also, the force acting on eachtether is reduced in order to reduce the likelihood of breakage and toprovide redundancy should one of the tethers break.

An alternative embodiment of a bariatric device 10″ may include aconnector 16″ having an a tension member 24 and a tether 26 including ananchor 60. Anchor 60 may be made up of an elongated member 62 having anouter surface 64 that is configured to promote tissue attachment, tissueingrowth and/or mucosal capture (FIGS. 32 and 33). Examples of suchsurface configuration are disclosed in commonly assigned InternationalPatent Application Publication No. WO 06/044640A1, entitled BARIATRICDEVICE AND METHOD and in commonly assigned provisional patentapplication Ser. Nos. 60/901,457 and 60/921,930 entitled BARIATRICDEVICE AND METHOD by Baker et al., the disclosures of which are herebyincorporated herein by reference. Anchor 60 extends from the loweresophagus to the cardiac region of the stomach through a passageextending outward of the GE junction. As previously described, thisallows normal functioning of the GE junction. Elongated member 62 has athrough opening, or lumen 63, that facilitates passage of tether 26.This ensures that the tether will not experience lateral migration.Also, the tether may be allowed to move longitudinally to provideadjustability to the strain exerted by the esophageal and/or cardiacportions. Bariatric device 10″ also includes a cardiac member 14″ havinga plurality of ribs 30 that are spaced radially about body 21″ in orderto impart additional stiffness to body 21″ if desired. Also, body 21″may include a surface feature 31 that is recessed to the approximatefootprint of cardiac member support 90 to enhance engagement of support90 with body 21″ during tether deployment

In use, anchor 60 can be positioned by the physician either as part ofthe procedure to deploy bariatric device 10″. Alternatively, anchor 60can be positioned several weeks before placement of the rest of thedevice. This allows time for tissue ingrowth to take place to firmlyhold the anchor in place. When the rest of the device is subsequentlypositioned, the physician can rely on the anchor being firmlypositioned.

In another embodiment, an anchor 160 includes an elongated member 162having an outer surface 164 that is configured to promote tissueattachment, tissue ingrowth and/or mucosal capture (FIG. 34). Anchor 160further includes one or more attachment mechanisms 65, which isillustrated as a loop but may be other configuration that allowsattachment to elongated member 162, such as by a fastener, or the like.Anchor 160 is illustrated without a lumen but may have one dependingupon the application. With one or more anchors 160 positioned in themanner previously described, it may serve as a mechanism for attachmentof a cardiac portion. The anchor(s) allow strain to be placed on thecardiac region of the stomach by a fastening system between the cardiacportion and the attachment mechanism 65. This facilitates a bariatricdevice having primarily only a cardiac member. Because the bariatricdevice does not pass at all through the GE junction, there is nointerference with normal function of the GE junction. Also, there is noneed for engagement with the esophagus.

While described as applying an outward force on the cardiac portion ofthe stomach, the bariatric device may, alternatively, apply an inwardforce on the cardia as would be apparent to the skilled artisan. Thismay be accomplished in various fashions, such as by providing tissueattachment, tissue ingrowth and/or mucosal capture openings on thecardiac member.

In another embodiment, an anchor 260 includes an elongated member 262having one or more appendages 58 extending from an outer surface 264(FIG. 35). Appendages 58 are configured to promote tissue attachment,tissue ingrowth and/or mucosal capture. This allows appendages 58 tobecome firmly attached in the wall of the stomach and/or esophagus, thusretaining anchor 260. Outer surface 264 may optionally include tissueattachment, tissue ingrowth and/or mucosal capture openings.

In yet another embodiment, an anchor 360 includes an elongated member362 having plates 57 at one or more ends of the elongated member (FIG.36). Each plate 57 includes mucosal capture openings 59. The mucosalcapture openings may be evenly spaced or may be in pairs to promotemucosal bridging. Once anchor 360 is positioned, the mucosa of theesophagus bulges the openings 59 of one plate 57 and the mucosa of thestomach bulges the openings 59 of the other plate 57. This mucosalcapture provides a more rapid retaining of anchor 360 in position asdisclosed in the '457 and '930 provisional patent applications. Themucosal capture can be expedited by using agents to promote scaringtogether of the mucosal portions across the bridge, such as by fibrosisgrowth. In the illustrated embodiment, a retainer, such as a cap, 55 maybe provided to fit over each plate 57 after the mucosa enters openings62. This applies a pressure on the mucosa to retain the mucosa and mayfurther force the mucosa together to stimulate bridging together of themucosa. Caps 55 can be retained on plate 57, such as by snap fit orother known techniques.

Anchor 360 may be removable. This is accomplished because the capturedmucosa can be removed, such as by ablation, chemical cautery,ultrasound, laser, or the like. One or both plates 57 can be maderemovable from elongated member 362. This allows anchor 360 to beremovable and, hence, the method reversible notwithstanding the use ofmucosal capture.

In another alternative embodiment, an anchor 460 has an elongated member462 made of complementary sections 462 a and 462 b (FIG. 37). Thesesections snap together in a lengthwise adjustable fashion, such that onesection may be inserted from the esophagus and one section from thestomach. Once engaged, further pressure causes a snap retention of thesections together to a desired length. Optionally, the length may beelongatable as well. Each section 642 a and 642 b may include a plate 57or an attachment mechanism (not shown).

An alternative bariatric device 134 includes an esophageal member 136, acardiac member 138 and a connector 140 (FIG. 38). In bariatric device134, connector 140 is a strap that is sufficiently rigid to properlyposition cardiac member 138 against the cardia without the requirementfor a tether or other connecting member. However, a tether may also beused.

An alternative bariatric device 142 includes an esophageal member 144, acardiac member 146, and a connector 148 (FIG. 39). Connector 148 isX-shaped with the center of the X positioned at the pseudo-sphincter ofthe GE junction. This allows the tension force to be distributed aroundmore of the circumference of the esophageal member 144 and the cardiacmember 146. As with bariatric device 134, the connector 148 forbariatric device 142 is a single-strap assembly that may be used with orwithout the use of a tether.

An alternative bariatric device 149 includes an esophageal member 150and a cardiac member 154 (FIG. 40). Esophageal member 150 may includetissue ingrowth openings 152 distributed along substantially the entiresurface of the wall defining the esophageal member. This promotes tissueingrowth along substantially the entire inner surface of the esophagealmember. Bariatric device 149 includes a connector made up of two or moretethers 153 placed opposite each other across the GE junction. Thetethers pass external the GE junction and allow substantiallyunrestrained operation of the pseudo-sphincter. Although only twotethers 153 are illustrated, more may be used and distributed around theGE junction.

An alternative bariatric device 166 and an alternative embodiment of adeployment procedure for bariatric device 166 include a cardiac member168 and an elongated shaft 170 for positioning the cardiac memberagainst the cardia (FIG. 41). Proximal force on shaft 170 causes a bulgeto be created at the GE junction to facilitate deployment of one or moretethers. An alternative tether assist device 172 is shown placing atether needle through the GE junction and engaging cardiac member 168.Once the tether(s) is attached to cardiac member 168, the shaft 170 canbe removed and any esophageal member (not shown) positioned in theesophagus and connected with the tether(s). Tether deployment device 172may be used as shown or in combination with a vacuum to draw in thetissue of the GE junction in order to produce a bulge facilitate firingthe tether pin through the tissue.

An alternative bariatric device 174 includes an esophageal member 176, acardiac member 178, and a connector 180 that is adjustable (FIGS. 42 and43). Connector 180 includes an adjustment system, such as a strap, 182connected with cardiac member 178 and an adjustment mechanism 184 at theesophageal member that adjusts the relative position of esophagealmember 176 with respect to the strap. It would be understood by theskilled artisan that strap 182 could be fixed to esophageal member 176,and the adjustment mechanism 184 fixed at cardiac member 178. Connector180 allows the position of the cardiac member 178 to be adjustedrelative to the esophageal member. This allows the amount of strainapplied to the cardia to be increased or decreased after bariatricdevice 174 is deployed. This allows the amount of satiety to be adjustedif the recipient is experiencing too much or too little satiety. Also,adjustment may be made at the time of deployment of bariatric device174. Alternatively, connector 180 may be adjusted by a control of thetype disclosed in International Publication No. WO 2006/044640 A1entitled BARIATRIC DEVICE AND METHOD, the disclosure of which is herebyincorporated herein by reference in its entirety.

An alternative bariatric device 186 includes an esophageal member 188, acardiac member 190 and a connector 192 (FIGS. 44 and 45). Cardiac member190 is a ring-shaped member. As best seen by comparing FIG. 44 and FIG.45, cardiac member 190 may be compressed in length during deployment andelongated after being deployed to the stomach. This may not only easedeployment of cardiac member 190, but also may allow cardiac member 190to apply strain in the form of elongation to the cardiac region inaddition to pressure against the cardiac region. Connector 192 may bemade up of a plurality of tethers that are placed inside of the GEjunction, although they could also be placed external of the GE junctionin a manner previously described. Because of their flexibility andplacement, tether(s) 192 leaves a continuous portion of gastroesophagealjunction substantially unrestrained.

An alternative bariatric device 194 includes a cardiac member 196 thatmay be similar to cardiac member 190 (FIG. 46). However, cardiac member196 may be anchored to the cardia, such as by utilizing an anchor, suchas a spiral tacker, 198 engaging the cardia, or the like. This appliesshear force to the cardia, thus stimulating both the tension receptorsand the stretch receptors more directly. While not shown, bariatricdevice 194 may optionally include an esophageal member and a connectorbetween the esophageal member and the cardiac member 196.

An alternative bariatric device 200 includes an esophageal member 202, acardiac member 204, and a connector 206 that are commonly formed from anelongated member 208 (FIG. 47). Elongated member 208 is formed into aspiral to form esophageal member 202, is axially extending in order toform connector 206, and is formed into another spiral in order to formcardiac member 204. Elongated member 208 may be a wire, such as aNitinol wire, a carbon filament, or the like. As best seen in FIG. 48,esophageal member 202 and/or cardiac member 204 may be covered with asleeve, such as silicone, in order to form a substantially smoothexternal surface in order to reduce erosion to the recipient's esophagusor cardia.

An alternative bariatric device 210 may include an esophageal member212, a cardiac member 214, and a connector 216 (FIG. 49). Cardiac member214 may be made from a relatively planar member that has memory, wherebythe planar member may be collapsed to pass through the recipient'sesophagus and self-expanded to the shape illustrated in FIG. 49 in orderto engage the cardia.

An alternative bariatric device 220 is in the form of a disk-shaped body222, which is fastened to the cardia by anchors at points 224 around itsperimeter (FIG. 50). Such fastening may be in the form of a spiraltacker, or other anchor. The presence of periphery anchoring is toprovide shear strain as well as pressure strain to the cardia. Anesophageal member and connector may optionally be used.

An alternative bariatric device 226 is made up of a series ofarticulated segments 228, which can be deployed in a linear fashion asillustrated in FIG. 52, but which form a ring-shaped device upondeployment, as illustrated in FIG. 51. Segments 228 can beinterconnected by living hinges 230, which may be biased into thecircular orientation of FIG. 51. The segments may be deployed through adelivery tube 232.

An alternative bariatric device 234 includes an esophageal member (notshown), a cardiac member 236, and a connector 238 that connects theesophageal member and the cardiac member (FIGS. 53 and 54). Connector238 is made up of one or more straps that are removable. This allows thephysician to substitute a strap having more or less flexibility foranother strap. This allows the stiffness of the connector to be tailoredto the recipient as well as adjusted after a period of time, as needed.Also, different length straps may be substituted. An insertion tool 240may be provided in order to insert the strap into the cardiac member 236and the esophageal member (not shown).

An alternative esophageal member 242 includes a series of peripheraltines 244 that assist in anchoring the esophageal member in the tissueat, or adjacent to, the GE junction (FIG. 55).

An alternative esophageal member 246 is anchored at or adjacent the GEjunction by a series of barbs or staples 248 that are applied after theesophageal member is deployed (FIG. 56).

An alternative bariatric device 250 has a cardiac surface that is madeup of a series of leafs 252 that are interconnected by a central ring254. Leafs 252 are spring-biased into the position illustrated in FIG.57, but may be folded for deployment. The leafs 252 are illustrated asbeing formed from an elongated member, such as Nitinol wire. They may becovered by a sleeve, or the like, in order to reduce mucosal erosion.

An alternative bariatric device 256 is similar to cardiac member 250except that leafs 258 are formed from a continuous elongated member,such as Nitinol wire (FIG. 58). However, leafs 258 may be folded fordeployment and self-expand to the form shown in FIG. 40 afterdeployment.

An alternative bariatric device 270 is in the form of a series ofpressure patches 272 (FIGS. 59 and 60). Each pressure patch 272 includesa resilient disk 274 and an anchor 276. The anchor is configured toengage the cardia and press the disk against the cardia. This allowseach pressure patch 272 to stimulate a portion of the cardia by applyingpressure to the cardia. Anchor 276 may be in the form of a spiralfastener, although others would be apparent to the skilled artisan.

A bariatric device 310 according to an alternative embodiment may,alternatively, apply a stretch force, such as a proximal/distal force,to the abdominal portion of the esophagus, the esophageal-gastricjunction, and/or the cardia. In the illustrative embodiment, bariatricdevice 310 includes a plurality of anchors, or studs, 311 positionedabout or around the cardiac region CR of the stomach (FIG. 61).Bariatric device 310 additionally includes a cardiac member in the formof a band 312 which applies a lateral force against studs 311. Band 312may be elastic and stretched upon application to apply a laterallyinward force on studs 311, as illustrated in FIG. 61. Alternatively,band 312 may be elastic and compressed upon application to apply alaterally outward force on studs 311. An optional mechanism, such as aclip, or the like, may be used to hold band 312 to studs 311. Studs maybe generally stiff or may be flexible according to the application.

In the illustrated embodiment, each stud 311 has a post 313 extendinginto the stomach and a support, such as a mesh 314 anchored in thestomach wall. The mesh may have tissue ingrowth, tissue attachment ormucosal capture openings to promote fixation to the mucosa, submucosaand/or muscularis. The studs may be applied in a separate procedurebefore the band 312 is applied to allow time for the studs to be firmlysupported. Alternatively, studs may be provided as disclosed in U.S.Pat. Nos. 6,991,643 B2 entitled MULTI-BARBED DEVICE FOR RETAINING TISSUEIN APPOSITION AND METHODS OF USE and 7,160,312 B2 entitled IMPLANTABLEARTIFICIAL PARTITION AND METHOD OF USE, the disclosures of which arehereby incorporated herein by reference. Studs 311 may be deployed usinga pointed deployment tool 316. This may be accomplished endoscopically.

Another alternative bariatric device 410 is similar to bariatric device310 in that it utilizes a plurality of anchors, or studs, 311 positionedabout the cardiac region CR of the recipient. A cardiac member in theform of a series of expansion members, such as expansion springs 412,may be applied between adjacent studs 311 to apply a lateral force tothe studs to apply a strain to the cardiac region to stimulate receptorsthere.

Another alternative bariatric device 10′″ includes an esophageal member12′″ and a cardiac member 14′″ that may be made of a generally resilientmaterial having sufficient flexibility to allow it to be compacted topass through the esophagus while having sufficient rigidity to allow itto transmit strain from a connector 16′″ to the cardiac region of thestomach, such as in the form of an outwardly directed force (FIGS.65-68). In the illustrated embodiment, body 21′″ of cardiac member 14′″is made from a molded silicone, embedded weave 23′″ of flexible wire,such as Nitinol wire. The weave increases tear resistance and stiffness.Body 21′″ may include a proximally raised portion 34 defining a flange.Flange 34 is configured to fit against the GE junction. This causes foodto be directed through opening 36 in body 21′″ while resisting the foodpassing between cardiac surface 22′″ and the wall of the stomach. In theillustrated embodiments, body 21′″ may be made from a material, such asa type of molded silicone that is substantially transparent to light.This allows the physician deploying device 10 to be able to bettervisualize placement of the device during its deployment as would beunderstood by the skilled artisan.

Esophageal member 12′″ may apply a tension to the distal esophagus, suchas an outwardly directed force over the area of surface 20′″. Esophagealmember 12′″ may include a cage 44′″ and an impervious wall 45′″ coveringcage 44′″. Wall 45′″ may be made from molded silicone, which, in thesame manner as body 21′″, may be substantially transparent to light toenhance visibility during deployment. Cage 44′″ may be made from anelongated member 50′″, which, in the illustrated embodiment, is anelastic member, such as Nitinol wire. Member 50′″ is formed as aninterwoven spiral. Esophageal member 12′″ additionally includes a cover58 over the proximal end of cage 44′″. Cover 58 provides additionalflexibility to the distal end of member 12′″ to further minimize thepotential for erosion or ulceration as well as to provide a betterengagement with the esophageal wall.

Connector 16′″ includes a tension member 24′″ may pass through opening36 and has a distal extension 38 b that gets incorporated into body 21′″of the cardiac member and a proximal extension 38 a that getsincorporated into esophageal member 12′″. Tension member 24′″ is definedby one or more strands of flexible wire, such as Nitinol wire coveredwith a molded silicone layer. Proximal extension 38 a and distalextension 38 b are extensions of the wire defining tension member 24′″.While extensions 38 a, 38 b are illustrated as woven with weave 23′″ andcage 44′″, it should be understood that they may also be an extension ofthe wires defining weave 23′″ and cage 44′″. Indeed, it is contemplatedthat cage 44, tension member 24, and weave 23 may be made from a singlestrand of flexible wire, such as Nitinol wire. While only one tensionmember 24′″ is illustrated, it would be possible to add a second onethat is radially opposite with respect to opening 36. The addition of asecond such tension member may reduce the likelihood of cardiac member14′″ being displaced during deployment by resisting torsional forcesplaced on the cardiac member. This may help to keep esophageal member12′″ and cardiac member 14′″ in better alignment, notwithstanding suchforces. However, the presence of a second tension member may undesirablyimpede normal functioning of the pseudo sphincter at the GE junction.

An alternative bariatric device 10″″ includes an esophageal member 12″″and cardiac member 14″″ (FIGS. 69 and 70). Esophageal member 12″″ issimilar to esophageal member 12′″ except that it includes a cover 58distally as well as one proximally. Cardiac member 14″″ is similar tocardiac member 14′″ except that it includes a mesh 23″″ of differentweave from mesh 23′″. In the illustrative embodiment, esophageal member12″″ has a length of 35 mm, a proximal diameter of 25 mm and a distaldiameter of 20 mm. It includes a connector 16′″ with a tension member24′″ having a length of 17 mm.

While previously described bariatric devices are illustrated as deployedin a recipient of unaltered anatomy, a modified form of such bariatricdevices could perform the same function in a stomach that has beenaltered by surgery, such as bariatric surgery. Thus, the size and shapeof the cardiac member, in particular, would be modified to theconfiguration of the stomach component of the altered anatomy to providea tension, such as an outward pressure, similar to the bariatric deviceused with an unaltered anatomy. For example, a bariatric device 410 isshown having an esophageal member 412 having a wall configured to thesize and shape of a portion of the esophagus connected by a connector416 with a cardiac member 414 having a wall configured to the size andshape of the cardiac region of a stomach that has undergone verticalbanded gastroplasty (FIG. 71). A bariatric device 510 is shown having anesophageal member 512 having a wall configured to the size and shape ofa portion of the esophagus connected by a connector 516 with a cardiacmember 514 having a wall configured to the size and shape of the cardiacregion of a stomach that has undergone a sleeve gastrectomy (FIG. 72). Abariatric device 610 is shown having an esophageal member 612 having awall configured to the size and shape of a portion of the esophagusconnected by a connector 616 with a cardiac member 614 having a wallconfigured to the size and shape of the cardiac region of a stomach thathas undergone a duodenal switch (FIG. 73). A bariatric device 710 isshown having an esophageal member 712 having a wall configured to thesize and shape of a portion of the esophagus connected by a connector716 with a cardiac member 714 having a wall configured to generallyconform to the size and shape of the cardiac region of the proximalpouch of a recipient that has undergone a gastric bypass procedure, alsoknown as a roux-en-y procedure (FIG. 74). Other examples will becomeapparent to the skilled practitioner. Previously described tethers maybe deployed as part of connectors 416, 516, 616 and 716.

The bariatric devices disclosed herein may be made in whole or in partfrom bioabsorbable materials or from non-absorbable materials.

The strain exerted by the bariatric device influences the neurohormonalfeedback mechanism present at the esophagus and/or stomach to causeweight loss. The strain that influences the neurohormonal feedbackmechanism present at the abdominal portion of the esophagus, theesophageal-gastric junction and/or the cardiac portion of the stomach isintended to be relatively consistent over as large an area as reasonablypossible. In contrast to prior proposed devices, such as restrictiondevices, which require that the recipient ingest food in order toinfluence neurohormonal feedback mechanisms, the embodiments of thebariatric device disclosed herein are effective in the absence of food.It also augments fullness caused by food.

The tissue attachment, tissue ingrowth and/or mucosal capture, whichresults from the tissue essentially at least partially incorporatingcertain embodiments of the bariatric device into the anatomy of therecipient, may provide resistance to the formation of microbial biofilmand thereby reduces the potential for infection, odor, and the like. Aswith all fixation techniques described herein, these may be used incombination with other fixation techniques. These anchoring techniquesmay be used to promote long-term deployment by incorporating the deviceinto the body of the recipient.

Although various embodiments are illustrated herein, it should beunderstood that the features disclosed in each embodiment may becombined as would be apparent to the skilled artisan. In addition toinfluencing a neurohormonal feedback mechanism of the recipient to causeweight loss, the bariatric devices embodied herein may be capable ofbeing anchored to the recipient and being retained in place for anextended period of time. Moreover, the various embodiments of thebariatric device, once deployed, are of a size and shape that wouldresist entering the pylorus should the bariatric device distally migrateoutside of the esophagus into the stomach or are sufficiently small topass through the intestines. This reduces the risk to the recipient. Therecipient would likely be aware of the distal migration of the devicebecause the recipient would, once again, experience increased hunger asa result of a reduction in satiety and/or metabolism. The physiciancould then insert an overtube in the recipient and reposition thebariatric device as previously described. Thus, it is unlikely that thebariatric device would migrate without notice and, would unlikely harmthe recipient should the device migrate.

The embodiments of a bariatric device disclosed herein can be used forweight control in animals as well as humans. It can be used for weightcontrol in children and adolescents as well as adults. It can be usedwith overweight and mildly obese recipients as well as with morbidlyobese recipients.

Thus, it is seen that the disclosed embodiment provides a new categoryof weight loss techniques. The embodiment advantageously utilizesmechanoreceptors, such as tension receptors, stretch receptors and/orbaroreceptors, such as those located at the abdominal portion of theesophagus and/or esophageal-gastric junction and/or the cardiac portionof the stomach of the recipient to cause weight loss. The disclosedembodiments provide a non-invasive or minimally invasive technique. Thedisclosed embodiments facilitate burping and vomiting and do notsubstantially interfere with other functions of the GE junctionpseudo-sphincter.

Changes and modifications in the specifically described embodiments canbe carried out without departing from the principles of the inventionwhich is intended to be limited only by the scope of the appendedclaims, as interpreted according to the principles of patent lawincluding the doctrine of equivalents.

1. A bariatric device, comprising: an esophageal member having anesophageal surface that is configured to generally conform to the shapeand size of a portion of the esophagus; a cardiac member having acardiac surface that is configured to generally conform to the shape andsize of a portion of the cardiac portion of the stomach; and a connectorconnected with said esophageal member and said cardiac member, whereinat least one chosen from (i) said esophageal member and (ii) saidcardiac member is adapted to stimulate receptors in order to influence aneurohormonal mechanism in the recipient sufficient to cause at leastpartial satiety by augmenting fullness caused by food and simulatingfullness in the absence of food; wherein said connector comprises afirst elongated member that is adapted to extend through the GE junctionand a second elongated member that is adapted to bypass the GE junctionthrough the esophageal and gastric walls.
 2. The bariatric device asclaimed in claim 1 wherein said connector leaves a contiguous portion ofthe GE junction substantially unrestrained.
 3. The bariatric device asclaimed in claim 1 wherein said first elongated member is madesubstantially of Nitinol.
 4. The bariatric device as claimed in claim 3including a coating over said first elongated member.
 5. The bariatricdevice as claimed in claim 1, wherein said first elongated member isconnected with said esophageal member and said cardiac member externalthe recipient and said second elongated member is adapted to beconnected in situ.
 6. The bariatric device as claimed in claim 1 whereinat least one of said first and second elongated members is adjustable inorder to adjust the spacing between said esophageal member and saidcardiac member.
 7. The bariatric device as claimed in claim 5 whereinsaid at least one of said first and second elongated members isadjustable by adjusting the length of said at least one of said firstand second elongated members in situ.
 8. The bariatric device as claimedin claim 1 including a plurality of said second elongated members thatare spaced apart from each other.
 9. The bariatric device as claimed inclaim 1, wherein said first elongated member comprises a tension memberand includes an adjustable portion that is adapted to adjust at leastone chosen from the length and the angular orientation of portions ofsaid first elongated member connected with said esophageal and cardiacmembers.
 10. The bariatric device as claimed in claim 9, wherein saidadjustable portion is adjustable in situ.
 11. The bariatric device asclaimed in claim 1 wherein said second elongated member comprises atether and wherein a length of said tether between said esophagealmember and said cardiac member being adjustable.
 12. The bariatricdevice as claimed in claim 11, wherein said tether comprises a filamentand a tube surrounding said filament to facilitate lengthwise movementof said filament.
 13. A bariatric device, comprising: an esophagealmember having an esophageal surface that is configured to generallyconform to the shape and size of a portion of the esophagus; a cardiacmember having a cardiac surface that is configured to generally conformto the shape and size of a portion of the cardiac portion of thestomach; and a tether connected with said esophageal member and saidcardiac member, wherein at least one chosen from (i) said esophagealmember and (ii) said cardiac member is adapted to stimulate receptors inorder to influence a neurohormonal mechanism in the recipient sufficientto cause at least partial satiety by augmenting fullness caused by foodand simulating fullness in the absence of food.
 14. The bariatric deviceas claimed in claim 13 wherein said tether leaves a contiguous portionof the GE junction substantially unrestrained.
 15. The bariatric deviceas claimed in claim 13, wherein said tether is adapted to bypass the GEjunction through the esophageal and gastric walls.
 16. The bariatricdevice as claimed in claim 15, wherein said tether is adapted to bypassthe GE junction at the angle of His.
 17. The bariatric device as claimedin claim 13 including at least one clamp adapted to secure an end ofsaid tether.
 18. The bariatric device as claimed in claim 17, whereinsaid at least one clamp comprises a body and a plurality ofthrough-openings in said body, said through-openings adapted to receivesaid at least one end of said tether and to allow one-way movement ofsaid body along said tether, wherein said body is movable in onedirection along said tether and resists movement in an oppositedirection.
 19. The bariatric device as claimed in claim 13 comprising aplurality of said tethers that are adapted to be spaced apart.
 20. Thebariatric device as claimed in claim 13 wherein said tether comprises anelongated filament.
 21. The bariatric device as claimed in claim 13,wherein said tether comprises at least one chosen from (i) Ethibondsuture, (ii) ePTFE, (iii) an elastic material, and (iv) substantiallynon-coated silk.
 22. The bariatric device as claimed in claim 13 whereinsaid tether includes a tissue attachment surface or a tissue ingrowthsurface.
 23. A bariatric device, comprising: an esophageal member havingan esophageal surface that is configured to generally conform to theshape and size of a portion of the esophagus; a cardiac member having acardiac surface that is configured to generally conform to the shape andsize of a portion of the cardiac portion of the stomach; and a connectorconnected with said esophageal member and said cardiac member, whereinat least one chosen from (i) said esophageal member and (ii) saidcardiac member is adapted to stimulate receptors in order to influence aneurohormonal mechanism in the recipient sufficient to cause at leastpartial satiety by augmenting fullness caused by food and simulatingfullness in the absence of food; wherein said cardiac member comprises agenerally planar member, wherein said planar member is defined by astiffening mesh and a generally flexible material over said mesh. 24.The bariatric device as claimed in claim 23 wherein said planar memberincludes a through-opening adapted to be positioned at the GE junctionand a sealing flange surrounding said through-opening.
 25. The bariatricdevice as claimed in claim 23 wherein said mesh is formed by anelongated member in an open weave pattern.
 26. The bariatric device asclaimed in claim 25 wherein said elongated member of said mesh is madefrom Nitinol wire.
 27. The bariatric device as claimed in claim 26wherein said esophageal member comprises a cage and a generally flexiblematerial over said cage.
 28. The bariatric device as claimed in claim27, wherein said cage comprises an elongated member that is formed as aninterwoven spiral.
 29. The bariatric device as claimed in claim 28wherein said elongated member of said cage comprises a Nitinol wire 30.The bariatric device as claimed in claim 29 wherein said connector ismade substantially from Nitinol wire.
 31. The bariatric device asclaimed in claim 30 wherein said Nitinol wire of said connector is anextension of said elongated member of said cage and said elongatedmember of said mesh.
 32. The bariatric device as claimed in claim 23wherein said esophageal member comprises a cage and a generally flexiblematerial over said cage.
 33. The bariatric device as claimed in claim32, wherein said cage comprises an elongated member that is formed as aninterwoven spiral.
 34. The bariatric device as claimed in claim 33wherein said elongated member of said cage comprises a Nitinol wire. 35.The bariatric device as claimed in claim 32 including a cover over atleast one end of said esophageal member.
 36. The bariatric device asclaimed in claim 35 including a cover over both ends of said esophagealmember.
 37. The bariatric device as claimed in claim 23 including asurface feature defined on said planar member opposite said cardiacsurface, said surface feature providing retention for a tether assistdevice against said planar member.
 38. A bariatric device, comprising:an esophageal member having an esophageal surface that is configured togenerally conform to the shape and size of a portion of the esophagus; acardiac member having a cardiac surface that is configured to generallyconform to the shape and size of a portion of the cardiac portion of thestomach; and a connector connected with said esophageal member and saidcardiac member, wherein at least one chosen from (i) said esophagealmember and (ii) said cardiac member is adapted to stimulate receptors inorder to influence a neurohormonal mechanism in the recipient sufficientto cause at least partial satiety by augmenting fullness caused by foodand simulating fullness in the absence of food; wherein said cardiacmember is configured to the size and shape of the cardiac region of arecipient with altered anatomy.
 39. The bariatric device as claimed inclaim 38 wherein said cardiac member is configured to the size and shapeof the cardiac region of a recipient having undergone at least onechosen from (i) a gastric bypass procedure, (ii) a vertical bandedgastroplasty, (iii) a sleeve gastrectomy, and (iv) a duodenal switch.40. A method of causing at least partial satiety in a recipient,comprising: providing a bariatric device comprising an esophageal memberhaving an esophageal surface that is configured to generally conform tothe shape and size of a portion of the esophagus, a cardiac memberhaving a cardiac surface that is configured to generally conform to theshape and size of a portion of the cardiac portion of the stomach, and aconnector connected with said esophageal member and said cardiac member,wherein said connector comprises a first elongated member and a secondelongated member; extending said first elongated member through the GEjunction and said second elongated member outside of the GE junctionthrough the esophageal and gastric walls; and stimulating receptors withat least one chosen from said esophageal surface and said cardiacsurface in order to influence a neurohormonal mechanism in the recipientsufficient to cause at least partial satiety by augmenting fullnesscaused by food and simulating fullness in the absence of food.
 41. Amethod of causing at least partial satiety in a recipient, comprising:providing a bariatric device comprising an esophageal member having anesophageal surface that is configured to generally conform to the shapeand size of a portion of the esophagus, a cardiac member having acardiac surface that is configured to generally conform to the shape andsize of a portion of the cardiac portion of the stomach, and a tetherconnected with said esophageal member and said cardiac member; andstimulating receptors with at least one chosen from said esophagealsurface and said cardiac surface in order to influence a neurohormonalmechanism in the recipient sufficient to cause at least partial satietyby augmenting fullness caused by food and simulating fullness in theabsence of food.
 42. The method as claimed in claim 42 includingconnecting said tether with said esophageal member and said cardiacmember in situ.
 43. A method of causing at least partial satiety in arecipient, comprising: providing a bariatric device comprising anesophageal member having an esophageal surface that is configured togenerally conform to the shape and size of a portion of the esophagus, acardiac member having a cardiac surface that is configured to generallyconform to the shape and size of a portion of the cardiac portion of thestomach, and a connector connected with said esophageal member and saidcardiac member, wherein said cardiac member is configured to the sizeand shape of the cardiac region of a recipient with altered anatomy;deploying said bariatric device to a recipient having an alteredanatomy; and stimulating receptors with at least one chosen from saidesophageal surface and said cardiac surface in order to influence aneurohormonal mechanism in the recipient sufficient to cause at leastpartial satiety by augmenting fullness caused by food and simulatingfullness in the absence of food.
 44. The method as claimed in claim 43including deploying said bariatric device to a recipient havingundergone at least one chosen from (i) a gastric bypass procedure, (ii)a vertical banded gastroplasty, (iii) a sleeve gastrectomy, and (iv) aduodenal switch.